NGM Bio Provides Business Highlights and Reports Fourth Quarter and Full Year 2021 Financial Results
March 01 2022 - 4:06PM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today provided business
highlights and reported financial results for the full year and
fourth quarter ending December 31, 2021.
“2021 was a meaningful year for NGM Bio. We made significant
progress advancing our pipeline, which now includes five programs
in the clinic, with four programs in Phase 2 trials,” said David J.
Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “2022 is
poised to be one of the most eventful years in NGM Bio’s history
with multiple milestones expected, including clinical data readouts
from three of our programs, continued development across our
pipeline and steady output from our research and discovery
engine.”
Key Fourth Quarter and Recent Highlights
Oncology
- Progressed the Phase
1/2 trial of NGM707, an ILT2/ITL4 dual antagonist antibody product
candidate, in patients with advanced solid tumors through multiple
dose cohorts in the Phase 1a monotherapy dose escalation. Initial
data readout from the Phase 1a portion of the trial is expected in
the second half of 2022.
- Continued to
progress the Phase 1 portion of the PINNACLES trial of NGM120, an
antagonist antibody product candidate that binds GFRAL and is
designed to inhibit GDF15 signaling. The PINNACLES trial is
evaluating NGM120 as a monotherapy in patients with advanced solid
tumors and in combination with gemcitabine and Nab-paclitaxel in
patients with metastatic pancreatic cancer. Additional clinical
data from the Phase 1a and Phase 1b cohorts is expected in the
second half of 2022.
- Continued enrollment
in the placebo-controlled Phase 2 portion of the PINNACLES trial,
evaluating NGM120 in combination with gemcitabine and
Nab-paclitaxel as a first-line treatment in patients with
metastatic pancreatic cancer.
Retinal disease
- Continued to advance
the fully enrolled Phase 2 CATALINA trial of NGM621 in patients
with GA. Topline data readout is expected in the fourth quarter of
this year.
- The FDA granted Fast
Track designation to NGM621 for the treatment of patients with GA
secondary to age-related macular degeneration in February
2022.
Liver and metabolic diseases
- Completed enrollment
in ALPINE 4, the Phase 2b trial of aldafermin in patients with
compensated NASH cirrhosis (F4 NASH), in January 2022. Topline data
readout is expected in the first half of 2023.
- Updated the design
of the ALPINE 4 trial, elevating the Enhanced Liver Fibrosis (ELF)
test, a reproducible, quantitative non-invasive liver prognostic
test that evaluates liver fibrosis and correlates to liver-related
outcomes to be the primary endpoint for the trial. The ELF test is
a composite blood test measuring the presence of three biomarkers
associated with liver matrix metabolism. Liver biopsy data will
also be measured and reported as a secondary endpoint upon
completion of the trial.
- Merck, known as MSD
outside of the United States and Canada, continued to progress
enrollment in a global Phase 2b trial of MK-3655 for the treatment
of non-cirrhotic (F2/F3) NASH. MK-3655 is an agonistic antibody
product candidate binding to fibroblast growth factor receptor
1c-beta-klotho that Merck licensed from NGM Bio.
Corporate Highlights
- Entered into a
clinical trial collaboration and supply agreement with Merck
related to NGM Bio’s ongoing Phase 1/2 trial of NGM707 in
combination with Merck’s KEYTRUDA® (pembrolizumab) in December
2021.
Fourth Quarter and Full Year 2021 Financial
Results
- NGM Bio reported a
net loss of $27.2 million and $120.3 million for the quarter and
year ended December 31, 2021, respectively, compared to a net
loss of $28.0 million and $102.5 million for the same periods in
2020.
- Related party
revenue from our collaboration with Merck was $21.0 million and
$77.9 million for the quarter and year ended December 31,
2021, respectively, compared to $19.8 million and $87.4 million for
the same periods in 2020. Related party revenue decreased $9.5
million in 2021 as compared to 2020 primarily due to the effects of
amending and restating our collaboration agreement with Merck in
June 2021.
- Research and
development (R&D) expenses were $38.7 million and $161.7
million for the quarter and year ended December 31, 2021,
respectively, compared to $40.1 million and $164.0 million for the
same periods in 2020. R&D expenses decreased $1.3 million in
the quarter as compared to the prior year period primarily due to
decreases in expenses for our manufacturing activities and our
clinical trials of aldafermin. R&D expenses decreased $2.3
million in 2021 as compared to 2020 primarily due to decreases in
expenses for our manufacturing activities and our clinical trials
of aldafermin partially offset by increases in personnel-related
expenses and external expenses driven by our ongoing clinical
trials of NGM621, NGM120 and NGM707 and our preclinical studies of
NGM438 and NGM831.
- General and
administrative expenses were $9.5 million and $36.9 million for the
quarter and year ended December 31, 2021, respectively,
compared to $7.4 million and $27.2 million for the same periods in
2020. The $9.6 million increase in general and administrative
expenses in 2021 was primarily attributable to increases in
compensation-related expenses driven by higher headcount and an
increase in expenses associated with being a public company.
- Cash, cash
equivalents and short-term marketable securities were $366.3
million as of December 31, 2021, compared to $295.2 million as
of December 31, 2020. NGM Bio believes its cash, cash
equivalents and marketable securities will be sufficient to fund
its planned operations into the first half of 2024.
About NGM Biopharmaceuticals, Inc.
NGM Bio is focused on discovering and developing novel,
life-changing medicines for people whose health and lives have been
disrupted by disease. The company’s biology-centric drug discovery
approach aims to seamlessly integrate interrogation of complex
disease-associated biology and protein engineering expertise to
unlock proprietary insights that are leveraged to generate
promising product candidates and enable their rapid advancement
into proof-of-concept studies. As explorers on the frontier of
life-changing science, NGM Bio aspires to operate one of the most
productive research and development engines in the
biopharmaceutical industry. All therapeutic candidates in the NGM
Bio pipeline have been generated by its in-house discovery engine,
with a disease-agnostic mindset, always led by biology and
motivated by unmet patient need. Today, the company has seven
disclosed programs, including four in Phase 2 or 2b studies, across
three therapeutic areas: cancer, retinal diseases and liver and
metabolic diseases. Visit us at www.ngmbio.com for more
information.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
Abbreviations (in Alphabetical Order)
F2/F3/F4 = stage 2 or 3 or 4 liver fibrosis; GFRAL=Glial
Cell-Derived Neurotrophic Factor Receptor Alpha-Like; GDF15 =
Growth Differentiation Factor 15; ILT2=Immunoglobin-Like Transcript
2; ILT4=Immunoglobin-Like Transcript 4; NASH=non-alcoholic
steatohepatitis
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as “will,” “may,” “expected,” “anticipates,”
“preliminary,” “enable,” “believed,” “designed,” “suggesting,”
“suggest,” “look forward,” “potentially,” “potential,” “promise,”
“goal,” “planned,” “plans,” “aspire,” “aim” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These statements include those related
to: the therapeutic potential of NGM Bio’s product candidates, NGM
Bio’s continued pipeline development and research and development
output; the design of NGM Bio’s and Merck’s clinical trials of NGM
Bio’s product candidates; the planned commencement of a Phase 1b
cohort of the Phase 1/2 trial of NGM707 and the anticipated timing
thereof; the availability and anticipated timing of the initial
data readout from the Phase 1a monotherapy dose escalation cohort
of the Phase 1/2 trial of NGM707; the availability and anticipated
timing of additional clinical data readouts from the Phase 1a and
Phase 1b cohorts of the Phase 1/2 PINNACLES trial of NGM120; the
availability and anticipated timing of topline data from the Phase
2 CATALINA trial of NGM621; the availability and anticipated timing
of the Phase 2b trial of aldafermin in patients with compensated
NASH cirrhosis; the sufficiency of NGM Bio’s cash, cash equivalents
and marketable securities to fund planned operations into the first
half of 2024; and other statements that are not historical fact.
Because such statements deal with future events and are based on
NGM Bio’s current expectations, they are subject to various risks
and uncertainties, and actual results, performance or achievements
of NGM Bio could differ materially from those described in or
implied by the statements in this press release. These
forward-looking statements are subject to risks and uncertainties,
including, without limitation, risks and uncertainties associated
with the costly and time-consuming pharmaceutical product
development process and the uncertainty of clinical success,
including risks related to failure or delays in successfully
initiating, enrolling, reporting data from or completing clinical
studies, as well as the risks that results obtained in clinical
trials to date may not be indicative of results obtained in ongoing
or future trials and that NGM Bio’s product candidates may
otherwise not be tolerable and effective treatments in their
planned indications; NGM Bio’s ability to maintain its amended
collaboration with Merck, including the risk that if Merck were to
breach or terminate the amended collaboration or Merck’s
development funding obligations, NGM Bio would not obtain all of
the anticipated financial and other benefits of the amended
collaboration, and the development and/or commercialization of NGM
Bio’s product candidates within the scope of the amended
collaboration could be delayed, perhaps substantially; the ongoing
COVID-19 pandemic, which has adversely affected, and could
materially and adversely affect in the future, NGM Bio’s business
and operations, including NGM Bio’s ability to timely supply,
initiate, enroll and complete its ongoing and future clinical
trials; the time-consuming and uncertain regulatory approval
process; NGM Bio’s reliance on third-party manufacturers for
aldafermin, NGM120, NGM707, NGM831, NGM621 and its other product
candidates and the risks inherent in manufacturing and testing
pharmaceutical products; the sufficiency of NGM Bio’s cash
resources, including to fund its wholly-owned programs, and NGM
Bio’s need for additional capital; and other risks and
uncertainties affecting NGM Bio and its development programs,
including those discussed in the section titled “Risk Factors” in
NGM Bio’s quarterly report on Form 10-Q for the quarter ended
September 30, 2021 filed with the United States Securities and
Exchange Commission (SEC) on November 4, 2021 and future filings
and reports that NGM Bio makes from time to time with the SEC.
Except as required by law, NGM Bio assumes no obligation to update
these forward-looking statements, or to update the reasons if
actual results differ materially from those anticipated in the
forward-looking statements.
Investor
Contact:Brian Schoelkopfir@ngmbio.com |
Media
Contact:media@ngmbio.com |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except share and per share
amounts)(Unaudited)
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
2020* |
Related party revenue |
$ |
20,959 |
|
|
$ |
19,767 |
|
|
$ |
77,882 |
|
|
$ |
87,368 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
38,729 |
|
|
|
40,060 |
|
|
|
161,712 |
|
|
|
163,972 |
|
General and administrative |
|
9,454 |
|
|
|
7,380 |
|
|
|
36,865 |
|
|
|
27,229 |
|
Total operating expenses |
|
48,183 |
|
|
|
47,440 |
|
|
|
198,577 |
|
|
|
191,201 |
|
Loss
from operations |
|
(27,224 |
) |
|
|
(27,673 |
) |
|
|
(120,695 |
) |
|
|
(103,833 |
) |
Interest
income, net |
|
85 |
|
|
|
116 |
|
|
|
420 |
|
|
|
1,939 |
|
Other
expense, net |
|
(95 |
) |
|
|
(434 |
) |
|
|
(60 |
) |
|
|
(593 |
) |
Net
loss |
$ |
(27,234 |
) |
|
$ |
(27,991 |
) |
|
$ |
(120,335 |
) |
|
$ |
(102,487 |
) |
Net
loss per share, basic and diluted |
$ |
(0.35 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.50 |
) |
Weighted average shares used to compute net loss per share, basic
and diluted |
|
77,779,419 |
|
|
|
69,370,960 |
|
|
|
77,085,405 |
|
|
|
68,475,378 |
|
___________ *
Derived from the audited consolidated financial statements.
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) (Unaudited)
|
December 31,2021 |
|
December 31,2020* |
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
151,795 |
|
|
$ |
147,017 |
|
Short-term marketable securities |
|
214,458 |
|
|
|
148,139 |
|
Related party receivable from collaboration |
|
4,945 |
|
|
|
333 |
|
Related party contract asset |
|
— |
|
|
|
6,100 |
|
Prepaid expenses and other current assets |
|
8,082 |
|
|
|
6,837 |
|
Total current assets |
|
379,280 |
|
|
|
308,426 |
|
Property
and equipment, net |
|
10,071 |
|
|
|
14,526 |
|
Operating lease right-of-use asset |
|
4,045 |
|
|
|
— |
|
Restricted cash |
|
1,499 |
|
|
|
1,499 |
|
Other
non-current assets |
|
7,492 |
|
|
|
4,592 |
|
Total
assets |
$ |
402,387 |
|
|
$ |
329,043 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
5,246 |
|
|
$ |
9,663 |
|
Accrued liabilities |
|
33,258 |
|
|
|
29,945 |
|
Operating lease liability, current |
|
5,077 |
|
|
|
— |
|
Deferred rent, current |
|
— |
|
|
|
2,975 |
|
Contract liabilities |
|
17,774 |
|
|
|
— |
|
Total current liabilities |
|
61,355 |
|
|
|
42,583 |
|
Operating lease liability, non-current |
|
5,385 |
|
|
|
— |
|
Deferred
rent, non-current |
|
— |
|
|
|
6,417 |
|
Total
liabilities |
|
66,740 |
|
|
|
49,000 |
|
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par value; |
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value; |
|
78 |
|
|
|
71 |
|
Additional paid-in capital |
|
754,664 |
|
|
|
578,599 |
|
Accumulated other comprehensive (loss) income |
|
(129 |
) |
|
|
4 |
|
Accumulated deficit |
|
(418,966 |
) |
|
|
(298,631 |
) |
Total
stockholders' equity |
|
335,647 |
|
|
|
280,043 |
|
Total
liabilities and stockholders' equity |
$ |
402,387 |
|
|
$ |
329,043 |
|
___________ *
Derived from the audited consolidated financial statements.
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